1. Field of the Invention
The invention relates to catheterization procedures and systems. In particular, it relates to a platform for holding supplies, devices, waste and fluids in front of the operator and over the patient.
2. Description of the Prior Art
Invasive vascular catheterization procedures employ numerous sterile equipment items to facilitate insertion of catheters through the skin and into big vessels of various organs for purposes of diagnosis by injection of contrast dyes, sampling of bodily fluids, removal of tissues and measurement of pressures. Such procedures are also performed for therapeutic reasons, including interventions to open blockages, ablate or remove abnormal tissue, instill medicines, etc. Such catheterization procedures are performed in sterile conditions in radiologic suites equipped with fluoroscopic/angiographic radiologic equipment. These procedures are performed with the patient lying on a fluoroscopic table and covered with sterile gowns and drapes, and performed by one or two sterilely gowned operators.
Although catheterization procedures vary according to the specific organ being investigated and as well by whether the procedure is diagnostic or therapeutic, there are basic equipment items that are common to all such procedures, these include: (1) preparatory solutions including iodine and alcohol, sterile sponges and sponge clamps, utilized to sterilely prepare the skin site for catheter entry; (2) sterile drapes and towels employed to cover the patient and thus provide a sterile field for performance of the procedure; (3) sterile drapes and sheets to cover the radiologic imaging tube and other equipment that may be upon or adjacent to the sterile field; (4) an equipment table that is used as a "staging area" for various equipment items; (5) sterile bowls for reservoirs of procedure dependent fluids (such as saline, heparin and lidocaine), and as storage receptacles for various catheterization equipment including guide wires, catheters, and various interventional devices (balloons); (6) disposable plastic syringes of various sizes for injection of procedure dependent fluids; (7) sterile 4.times.4's (also known as gauze pads or sponges); and (8) miscellaneous other disposable instruments including scalpel and/or scalpel blades, various size disposable needles for injection of procedure dependent fluids, hemostats and towel clamps.
To prepare for the procedure, a prepackaged "tray" containing many of the disposable equipment items enumerated (i.e. drapes, bowls, syringes, needles, hemostat, scalpel, etc., but not including the vascular access sheaths, catheters, wires or balloons) is placed on an equipment staging table (positioned near the fluoroscopy table), opened and disassembled. The patient is draped with sterile sheets, the equipment items are arranged on the equipment staging table, appropriate preparatory steps initiated (i.e. bowls filled with saline, cups with lidocaine, etc.), and the catheterization procedure is initiated. During the catheterization procedure itself, there is a near constant flow of steps and manipulations that require various pieces of equipment at various times; these motions include handling of syringes, sponges, hemostats, scalpels and syringes filled with procedure dependent fluids, as well as sheaths, wires, catheters, and interventional devices. Accordingly, there is a constant flow of motion between the operators (whose attention should be primarily and optimally would be constantly focused on the patient and the physiologic monitors for blood pressure, heart rhythm and radiologic imaging positioned next to and facing the patient), and these intermittently used equipment items. Unfortunately, as presently performed, many of the procedure dependent equipment items are kept on the equipment staging table which is nearly always positioned behind the operators. This arrangement necessitates the operators to be constantly turning around to replace or retrieve needed equipment items to perform equipment related maneuvers (access to wires, balloons and syringes, disposal of waste blood, etc.), thereby necessitating that their hands leave the primary catheterization equipment items, diverting their attention from the patient and the critical physiologic monitors, exposing the operators backs to potential radiation and interrupting what otherwise would be a much more efficient flow of the procedure. In addition, the catheters, manifold with plastic tubing, injection syringe and associated other equipment items (pacemakers, pacemaker generators, intra-aortic balloon pumps, indeflators for interventions) are typically placed directly in the patient's "lap" while "in-use". Furthermore, the "in-use" manipulation of these devices actually occurs in the patient's lap (on their groin-legs), which is used as a procedure "platform". Also, it is not uncommon for operators to leave various equipment items (such as needles, scalpels, syringes, sponges, sheaths, wires, etc.) not immediately "in-use" in the patient's "lap", these equipment items being left there in great part because constant turning around to replace and retrieve these items disrupts the flow of the procedure. A fundamental principle of such procedures is that efficiency in time and economy of motion facilitates performance of the procedure itself, thereby translating into better patient outcomes, particularly in critically ill patients and/or in those with very complex procedures in which efficiency of time and motion is essential to procedural success. Furthermore, given the high volume of cases performed in most laboratories, and the complex, demanding and often time-consuming nature of such studies, improvements in economy of motion and procedure time could potentially benefit "throughput" in the laboratory, and thereby be more economical.
Therefore, there is a need for a catheterization procedure equipment management system that would facilitate more efficient interaction of the operators with the various procedure dependent equipment items. Specifically, there is need for a system that would allow the operators to always be facing the patient and the physiologic monitors, with the equipment items within easy hands reach without turning around, without losing manual contact with the primary procedure dependent equipment (catheters, wires, balloons, etc.) nor losing contact with the critical safety net of the patient's physiologic and radiologic imaging monitors.